Sanrace Biotechnology Co., Ltd. – FDA Warning Letter, Sep 9, 2025

Sanrace Biotechnology Co., Ltd. received an FDA Warning Letter on October 22, 2026, following a review of records requested in September 2025. The review revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for over-the-counter drug products manufactured at their facility in Zhejiang, China.

The primary violations involve the failure to test raw materials for identity and safety. Specifically, the company did not adequately test high-risk ingredients for hazardous contaminants, which is a critical safety requirement to prevent poisoning. Furthermore, the firm lacked process validation protocols, meaning they could not demonstrate that their manufacturing processes consistently produce quality products. The FDA also found the company"s Quality Control Unit to be ineffective, noting a lack of oversight in water system monitoring and the absence of a complete stability testing program to ensure products remain effective throughout their shelf life.

Under the Federal Food, Drug, and Cosmetic Act, these failures categorize the company"s products as adulterated. As a result, the FDA placed the firm on an import alert in September 2026, effectively blocking their products from entering the U.S. market. To resolve these issues, the company must provide a written response within 15 business days detailing their corrective actions. The FDA strongly recommends hiring a professional consultant to perform a comprehensive audit and ensure the facility meets all regulatory standards. Continued non-compliance may lead to further legal action or the permanent refusal of product entry into the United States.